– Company’s safeCircle™ Testing Program to Monitor for COVID-19 Among On-Campus Unvaccinated Populations –
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, today announced that its wholly-owned subsidiary, Applied DNA Clinical Labs, LLC, (ADCL) was awarded a testing contract by Suffolk County Community College (the “College”) to monitor for the prevalence of COVID-19 among its unvaccinated staff and faculty in support of the College’s reopening in the fall (the “Contract”). Testing is scheduled to begin in the second half of September 2021. The College, part of the State University of New York (SUNY) system, is aligned with SUNY’s vaccination mandate, which requires all on-campus students to be fully vaccinated against COVID-19 by September 27, 2021.
The initial Contract term is one year and includes two one-year options for renewal exercisable at the College’s discretion. The Contract contains no minimum testing requirement; it stipulates a fixed monthly fee for sample collection site services and a separate fixed fee per individual COVID-19 test.
Suffolk County Community College is a public community college funded in part by Suffolk County, New York. The College was founded in 1959 and has three campuses located in Selden, Brentwood, and Riverhead, New York. Full-time and adjunct faculty number approximately 2,000 individuals. The College’s student population comprises about 25,000 full- and part-time students.
Under the Contract, ADCL will deploy safeCircle™, its high-throughput, pooled COVID-19 testing program, to provide cost-effective COVID-19 testing. Testing will be conducted at ACDL’s CLEP/CLIA-certified laboratory using the Company’s Linea™ COVID-19 Assay Kit both in a pooled screening modality and to perform reflex individual diagnostic testing of samples contained in a positive pool. ADCL will serve as prime contractor with subcontractor CLEARED4’s health verification platform to be used for appointments, sample tracking, reporting, program management, and mobile access pass visibility.
“Suffolk County Community College joins new safeCircle client The City University of New York, as well as several existing higher education institution clients, who have turned to us for COVID-19 testing to support their 2021-2022 academic year,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “As colleges and universities prepare to safely return to on-campus instruction armed with a powerful tool of vaccine mandates, nevertheless the emergence of the Delta Variant of Concern and its demonstrated reduction on vaccine efficacy make persistent COVID-19 testing a critical component of a comprehensive virus mitigation strategy. In these exceptional times, safeCircle affords administrators peace of mind with its highly accurate, affordable, and turnkey pooled testing program that can adjust to meet evolving testing requirements to help keep classrooms open and keeps student, faculty, and staff populations safe.”
ADCL’s high throughput pooled testing program, known as safeCircle™, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides rapid results using real-time PCR (RT-PCR) testing.
Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle
About the Linea™ COVID-19 Assay Kit
The Linea™ COVID-19 Assay Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider (HCP). The test is also intended for use with anterior nasal swab specimens that are self-collected in the presence of an HCP from individuals without symptoms or other reasons to suspect COVID-19 when tested at least weekly and with no more than 168 hours between serially collected specimens.
The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies.
The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
Leveraging its deep expertise in nucleic acid-based technologies, the Company has also established safeCircle™, a pooled COVID-19 testing program that is grounded in the Company’s EUA-authorized Linea™ COVID-19 Assay Kit. safeCircle is designed to look for infection within defined populations or communities utilizing pooled testing methodologies that increase testing efficiencies. The Company has also developed and plans to seek EUA-authorization for its Linea™ SARS-CoV-2 Mutation Panel, an assay-based panel for the detection of certain SARS-CoV-2 genetic mutations.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’
Applied DNA is a member of the Russell Microcap® Index.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance (including for our COVID-19 diagnostic and other testing offerings), the unknown amount of revenues and profits that will result from our safeCircle COVID-19 testing contracts, the possibility that the Linea Assay Kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidance promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 testing, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 17, 2020, and Quarterly Reports on Form 10-Q filed on February 11, 2021, May 13, 2021 and August 12, 2021, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.